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Progress Report on Information Management System for EAC Medicines Registration

This report outlines the objectives and progress of the Information Management System (IMS) for medicines registration within the East African Community (EAC). It discusses the operational framework, business processes in areas like medicines and food regulation, and the proposed system design to enhance interconnectivity among partner states. We emphasize sustainability through human resources, technological support, and training. This initiative aims to improve regulatory efficiency and public health by ensuring a unified approach to drug regulation across EAC member states.

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Progress Report on Information Management System for EAC Medicines Registration

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  1. JUMUIYA YA AFRIKA MASHARIKI EAST AFRICAN COMMUNITY Presented by: NATIONAL STAKEHOLDERS CONSULTATION MEETINGS Progress Report for Technical Working Group on Information Management System (IMS)

  2. PRESENTATION OUTLINE • Objectives of the IMS • Activities for information management system • Business processes • Proposed system design

  3. OBJECTIVES OF THE IMS • To implement a common information management system for medicines registration/regulation in each of the EAC Partner States’ NMRAs which are linked in all Partner States and EAC Secretariat. • Common information management system for drug registration/regulation operational in all EAC Partner States’ NMRAs and linked regionally by end of year 4

  4. ACTIVITIES

  5. Business Processes Business Processes Analysis in: • Medicines • Food • Medical Devices • Cosmetics • GMP • Import/Export • Clinical Trials • Waste Management/Disposal

  6. PROPOSED SYSTEM DESIGN

  7. SUMMARY ON SYSTEM IMPLEMENTATION ARCHITECTURE • Currently we are in Circle B – Business Architecture • BPA has been done for various processes.

  8. High Emphasis • Financial model for the development and implementation of the project needs to factor in: • Cyber Security • Hosting Services • User support and capacity building • Interoperability with other systems • None-infrastructure costs like e-readiness study • Change management issues.

  9. Request to the National Stakeholders To consider and approve the developed draft documents for further processes: • EAC Model for IMS Systems Architecture And Platform Implementation Also • -To continue supporting the national and regional initiatives and efforts that are towards the improvement of lives • -To continue participating in the approval processes that will follow at the regional level

  10. RECOMMENDATION • Sustainability of the IMS project post implementation should focus on the areas of: • Human Resource (users) • Technology support (programmers and system administrators) • Finance (Licensing costs) • Training.

  11. FUTURE PROJECTIONS • The IMS TWG has only one projection. SUCCESS

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